Respiratory Impact of LA Volume After IS Block

Respiratory Impact of Local Anaesthetic Volume for an Interscalene Brachial Plexus Block With an Extrafascial Approach.

The hypothesis of this study is that a reduced extrafascial volume of local anesthetic for an interscalene brachial plexus block is associated with a lower incidence of diaphragmatic hemiparalysis after an arthroscopic surgery of the shoulder, without any reduction of the analgesic efficacy.

Study Overview

• Status: Completed
• Conditions: Arthroscopic Surgery of the Shoulder; Extrafascial Interscalene Plexus Brachial Block
• Intervention / Treatment: Drug: Ropivacaine 0.75% Injectable Solution; Drug: Ropivacaine 0.75% Injectable Solution

Detailed Description

The hypothesis of this study is that a reduced extrafascial volume of local anesthetic for an interscalene brachial plexus block is associated with a lower incidence of diaphragmatic hemiparalysis after an arthroscopic surgery of the shoulder, without any reduction of the analgesic efficacy.

Our prospective randomized controlled trial will include two parallel groups: a group will receive a volume of 20 mls of ropivacaine 0.75%, while the other group will receive a volume of 10 mls.

All participants will have a preoperative ultrasound-guided interscalene brachial plexus with an extrafascial injection of 10 or 20 mls of ropivacaine 0.75%. In both groups, participants will have an examination of the hemidiaphgragm with the ultrasound, before and 30 min after the block. The respiratory function will also be assessed with a bedside spirometer before and after the block, and at 12 and 24 postoperative hours. During surgery all participants will receive multimodal analgesia inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 milligram kg^2, iv ketorolac 30 milligrams, and iv acetaminophen 1000 milligrams, according to the current practice in our institution. In the postoperative period, Participants will be prescribed an IV pca of morphine.

Assignment to one of these two groups will be done according to a computer-generated list of random numbers, and the sealed envelopes method will be used.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Eric Albrecht; Phone Number: 0041795566341; Email: eric.albrecht@chuv.ch
• Study Contact Backup: Name: Erin Gonvers; Phone Number: 0041795560194; Email: erin.gonvers@chuv.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • CHUV (centre hospitalier universitaire vaudois)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• arthroscopic surgery of the shoulder
• ASA class 1 to 3
• age more than 18 years old

Exclusion Criteria:

• patient refusal or inability to understand and/or sign the inform consent
• contraindication for perineural block (allergy to local anesthetics, infection of puncture site, major coagulopathy, sensitive or motor deficiency on the operative side arm
• chronic alcool abuse
• opioid drug abuse or under substitution treatment
• patients known for allergies to paracetamol, non steroidal anti inflammatory drugs, dexamethasone, sulfate magnesium, ondansetron, droperidol, and omeprazole;
• patients under chronic corticotherapy
• patients known for malignant hyperthermia;
• patients with chronic kidney failure (Glomerular Filtration Rate < 20 ml/min)
• patients with severe pulmonary disease
• patients with history of neck surgery or radiotherapy on the operative side;
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 ml single-shot injection; In the 10ml group, participants will have an interscalene brachial plexus with an extrafascial injection of 10 ml ropivacaine 0.75% at the level of C5-C6 nerves roots. Participants will also receive multimodal analgesia with injection of dexamethasone 8 mg iv, magnesium sulfate 40 mg kg^-1 iv, ketorolac 30 mg iv, and acetaminophen 1000 mg iv, according to the current practice in our institution.	Drug: Ropivacaine 0.75% Injectable Solution; 10 ml extrafascial interscalene brachial plexus block; Drug: Ropivacaine 0.75% Injectable Solution; 20 ml extrafascial interscalene brachial plexus block
Active Comparator: 20 ml single-shot injection group; In the 20ml group, participants will have an interscalene brachial plexus with an extrafascial injection of 20 ml ropivacaine 0.75% at the level of C5-C6 nerves roots. Participants will also receive multimodal analgesia with injection of dexamethasone 8 mg iv, magnesium sulfate 40 mg kg^-1 iv, ketorolac 30 mg iv, and acetaminophen 1000 mg iv, according to the current practice in our institution.	Drug: Ropivacaine 0.75% Injectable Solution; 10 ml extrafascial interscalene brachial plexus block; Drug: Ropivacaine 0.75% Injectable Solution; 20 ml extrafascial interscalene brachial plexus block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of hemidiaphragmatic paralysis	30 minutes after the interscalene plexus brachial extrafascial injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hemidiaphragmatic paralysis		at 2 and 24 postoperative hours
Presence of Dyspnea	Verbal question to the patient if he has dyspnea or not	in phase 1 recovery and at 12 and 24 postoperative
Presence of PONV	Verbal question to the patient if he has dyspnea or not	in phase 1 recovery and at 12 and 24 postoperative
Presence of Pruritus	Verbal question to the patient if he has pruritus or not	in phase 1 recovery and at 12 and 24 postoperative hours
Presence of Claude-Bernard-Horner syndrome	Examination of the patient	in phase 1 recovery and at 12 and 24 postoperative hours
Presence of Dysphonia	Verbal question to the patient if he has dysphonia or not	in phase 1 recovery and at 12 and 24 postoperative hours
Forced expiratory volume in one second	in liters per second	30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
Forced vital capacity	in liters	30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
Peak expiratory flow	in liters per second	30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
Installation time of sensory block	in minutes	up to 30 minutes after the interscalene plexus brachial extrafascial injection
Installation time of motor block	in minutes	up to 30 minutes after the interscalene plexus brachial extrafascial injection
Time to first dose of postoperative iv morphine	in hours	up to 24 hours postsurgery
Pain scores at rest	Numeric pain intensity scale. Pain scores range from zero (no pain) to 10 (worst possible pain)	in phase 1 recovery and at 12 and 24 postoperative hours
Pain scores on movement	Numeric pain intensity scale. Pain scores range from zero (no pain) to 10 (worst possible pain).	in phase 1 recovery and at 12 and 24 postoperative hours
Cumulative postoperative iv morphine consumption	in milligrams	in phase 1 recovery and at 12 and 24 postoperative hours
Duration of analgesic block	in minutes	up to 24 hours postsurgery
Duration of motor block	in minutes	up to 24 hours postsurgery
Duration of sensory block	in minutes	up to 24 hours postsurgery
Satisfaction of the participants	Numeric satisfaction intensity scale. Satisfactions range from 0 (totally unsatisfied) to 10 (maximal satisfaction).	at 24 postoperative hours

Collaborators and Investigators

• Sponsor: Eric Albrecht

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): November 20, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Ropivacaine
• Other Study ID Numbers: 2020-02930

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No